Clinical Trial: Use of Corticosteroids in Children With Cellulitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Use of Corticosteroids in Children Hospitalized With Cellulitis: Randomized, Double Blind, Placebo Controlled Trial

Brief Summary: The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to antibiotic treatment during the first 48 hours of admission to the hospital in patients with cellulitis and its impact in the duration of the stay.

Detailed Summary:

Cellulitis is a common skin and soft tissue infection in the pediatric population.

Although most of the time treatment could be administered on an ambulatory setting , sometimes it may require hospitalization and parenteral antibiotic administration. Using corticosteroids during antibiotic treatment may reduce inflammation and length of stay.

Objective: to evaluate the efficacy of using corticosteroids as adjuvant treatment during the first 48 hours of treatment after hospitalization in patients with cellulitis.

Patients and methods: this is a double blind, randomized, controlled trial that will take place at pediatric hospital, during one year. It will include children aged 1 month to 18 years, admitted due to cellulitis. Once included in the clinical trial, the patients will be randomized to receive dexamethasone 0,6 mg/kg/day or placebo (saline solution) during the first 48 hours. Considering an average stay of 4 ± 2 days, we calculated a sample size of 124 children (62 children per group) to detect a 25% difference (1 day reduction) in the length of stay, with a power of 80% and a confidence of 95%.


Sponsor: Hospital General de Niños Pedro de Elizalde

Current Primary Outcome: Length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fever duration [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Change in erythema size [ Time Frame: Measured at admission and after 48 hours (at the end of corticosteroids treatment) ]
  • Need to change antibiotic treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
  • Abscessation or spontaneous drainage [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]


Original Secondary Outcome: Same as current

Information By: Hospital General de Niños Pedro de Elizalde

Dates:
Date Received: February 19, 2014
Date Started: June 2014
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017